NCT05646433

Brief Summary

We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management. This score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality. In a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

December 3, 2022

Last Update Submit

July 3, 2023

Conditions

Gastro Intestinal Bleed

Keywords

Upper Gastro intestinal bleeding; TU-GIB score; ED

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was all-cause in-hospital mortality rate

    The primary outcome was all-cause in-hospital mortality rate

    30 days after inclusion

Secondary Outcomes (1)

  • re-bleeding, re-hospitalization, discharge

    30 days after inclusion

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

multicentric, descriptive and analytical study in different emergency departments

You may qualify if:

  • patients consulting the emergency room for upper GI hemorrhage of non-traumatic origin.
  • Age \>18 years

You may not qualify if:

  • patient under the age of 18
  • Lower gastrointestinal hemorrhag
  • diagnosis of external hemorrhoids / perianal lesions
  • Not consenting
  • The lost sight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahloul University Hospital

Sousse, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Riadh Boukef, professor

CONTACT

0021698676745riadboukef@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

December 3, 2022

First Posted

December 12, 2022

Study Start

June 2, 2023

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

TU(1)